What are "Novel" Drugs?
"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
FDA Novel Drug Therapy Approvals for 2026
No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 29. Simtriyo centanafadine 7/24/2026 To treat attention-deficit hyperactivity disorder 28. Lytenava bevacizumab-vikg 7/24/2026 To treat patients with neovascular (wet) age-related macular degeneration 27. Jideytro zidesamtinib 7/22/2026 To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitor 26. Lipfendra enlicitide decanoate 7/15/2026 To reduce low-density lipoprotein cholesterol 25. Revtorpyk gedatolisib 7/14/2026 In combination with fulvestran, to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting 24. Trutakna atacicept-vymj 7/7/2026 To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression 23. Lumvoa veligrotug-vvze 6/26/2026 To treat thyroid eye disease 22. Utebzi tebipenem pivoxil 6/17/2026 To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options 21. Ambelvist gadoquatrane 6/12/2026 To detect and visualize lesions with abnormal vascularity, in conjunction with MRI 20. Cypsedo cipepofol 5/29/2026 To induce general anesthesia in adults undergoing surgery 19. Xocova ensitrelvir 5/29/2026 To use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19 18. Zaynich cefepime and zidebactam 5/29/2026 To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms 17. Decnupaz pivekimab sunirine-pvzy 5/27/2026 To treat adults with blastic plasmacytoid dendritic cell neoplasm Drug Trials Snapshot 16. Hepcludex bulevirtide-gmod 5/22/2026 To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis 15. Baxfendy baxdrostat 5/15/2026 To treat hypertension in combination with other antihypertensive drugs 14. Beqalzi sonrotoclax 5/13/2026 To treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor 13. Veppanu vepdegestrant 5/1/2026 To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy 12. Idvynso doravirine and islatravir 4/20/2026 To treat HIV-1 infection (as a complete regimen) in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine 11. Foundayo orforglipron 4/1/2026 To reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition, in combination with a reduced-calorie diet and increased physical activity 10. Awiqli insulin icodec-abae 3/26/2026 To improve glycemic control in adults with type 2 diabetes mellitus 9. Lifyorli relacorilant 3/25/2026 To treat platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic treatment regimens, at least one of which included bevacizumab 8. Avlayah tividenofusp alfa-eknm 3/24/2026 To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II) 7. Icotyde icotrokinra 3/17/2026 To treat moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy 6. Lynavoy linerixibat 3/17/2026 To treat cholestatic pruritus associated with primary biliary cholangitis 5. Yuviwel navepegritide 2/27/2026 To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses 4. Loargys pegzilarginase-nbln 2/23/2026 To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction 3. Bysanti milsaperidone 2/20/2026 To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder 2. Adquey difamilast 2/12/2026 To treat mild to moderate atopic dermatitis 1. Zycubo copper histidinate 1/12/2026 To treat Menkes disease Drug Trials Snapshot
*The listed “FDA-approved use” on this page is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, please see the most recently approved Prescribing Information (or Label) available at Drugs@FDA. You can search by drug name, active ingredient, or application number.